Fatty acids, coco derivs., reaction products with glycine, potassium salts

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.09.2012 to 25.09.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Light microscopy measurements (digital microscope consisting of the main unit VHX-1000 D, the camera unit VHX-1100 and a zoom objective VH-Z250R; Keyence Corp., Osaka, Japan) were conducted in respect to the particle size distribution. Ca. 3 mg acylglycinate were suspended in 5 mL acetone. The suspension was shaken and stirred for 30 sec and then filled into a counting chamber. The counting chamber was positioned under the digital microscope for analysis. In total, 198 particles were analysed and the geometric and the aerodynamic diameters determined.

GLP compliance:

yes (incl. QA statement)

Remarks:

Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM), Nikolai-Fuchs Straße 1, D-30625 Hannover, Germany

Type of method:

microscopic examination

Type of particle tested:

primary particle

Type of distribution:

counted distribution

Test material

Test material information

Constituent 1

Reference substance name:

dipotassium 2-dodecanamidoacetate 2-tetradecanamidoacetate

EC Number:

620-582-5

Cas Number:

301341-58-2

Molecular formula:

R-CO-NH-CH2-COOK (Note: "R-CO-" is a fatty acid residue)

IUPAC Name:

dipotassium 2-dodecanamidoacetate 2-tetradecanamidoacetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: particulates

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-Ku, Tokyo 104-8315, Japan/Lot/Batch No.: 110825
- Expiration date of the lot/batch: 25.08.2014
- Purity test date: 24.01.2012

Results and discussion

Mass median aerodynamic diameter:

11.3 µm

Geometric standard deviation:

1.7

Particle size

Particle size 1

Key result

Percentile:

other: <10%

Mean:

5.44 µm

St. dev.:

1.7

Particle size 2

Key result

Percentile:

other: <50%

Mean:

10.45 µm

St. dev.:

1.7

Particle size 3

Key result

Percentile:

other: <90%

Mean:

22.48 µm

St. dev.:

1.7

Particle size distribution at different passages

Remarks on result:

other: not determined

Applicant's summary and conclusion

Conclusions:

The measurement of the particle size distribution of acylglycinate GCK-11 -T yielded a geometric mean diameter of 10.7 µm and a calculated aerodynamic diameter of 11.3 µm. Based on these results, the test item is practically not respirable.

Executive summary:

The particle size distribution of acylglycinate GCK-11 -T was investigated using a digital microscope. The geometric mean diameter and the calculated aerodynamic diameter were found to be 10.7 and 11.3 µm, respectively. Based on these results, the test item is practically not respirable.